GenePOC® CDiff Test Approved by Health Canada

The GenePOC CDiff assay is a qualitative in vitro diagnostic test to detect the toxin B (tcdB) gene of toxigenic C. difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI).

“The approval of our CDiff assay by Health Canada for the diagnostic of toxigenic C. difficile is in line with the objectives of control and prevention of this nosocomial infection,” said Patrice Allibert, PhD, CEO of GenePOC.

“In one step and within only seventy minutes, a CDI can be identified. Our molecular tests, used with the revogene instrument, have demonstrated to provide specific, sensitive and timely identification of patients with toxigenic CDI. Moreover, they are easy to use and affordable, which aligns well to the current needs of our health care system” concluded Patrice Allibert.

It is important to mention that earlier this year, GenePOC received the Health Canada approval and launched its first rapid diagnostic assay for the detection of group B Streptococcus from LIM broth enrichments. Therefore, it is their second Health Canada approval this year.

Professor Michel G. Bergeron, M.D., added: “C. difficile kills approximately 3000 Canadians a year. Rapid diagnosis using GenePOC’s unique technology, initially developed in my laboratory at University Laval in Québec City, will save many lives while controlling its costly dissemination in hospitals.”

The GenePOC CDiff test has been developed with the financial support of the FPQIS (Fonds de partenariat pour un Québec en santé).

The revogene is an automated and stand-alone instrument. It enables testing of single-use proprietary microfluidic cartridges, called PIEs, with its fluorescence-based real-time polymerase chain reaction platform to deliver an accurate diagnosis. In 2017, the revogene received the prestigious prize by Frost & Sullivan for the New Product Innovation3 as well as the Red Dot Award Best of the Best – Product Design